Controversial Brazilian Dispensing Decree Gains Suppor

March 31, 2005

A broad alliance of consumer groups, health professionals, trade unions and local drugmakers has voiced support for a controversial new Brazilian law enabling pharmacists to split up and repackage drug products. The new regulation, purportedly intended as a safety measure to prevent consumers from stockpiling expired drugs, has already attracted widespread accusations that it will allow greater penetration of cheap copy drugs in the country.

The 30 groups that have handed in a petition supporting the new law, which is known as Decree 5348, have cited successful examples of the practice in regulated markets including the Netherlands, the UK, Canada and the US. Government agencies including health regulator Anvisa have also added to the calls for full implementation of the law, which has recently been debated in Brazil's Congress.

Official support no doubt arises from research suggesting that the measure could cut drug costs for both government and consumers by as much as 20%. Although this would have the positive effect of encouraging public access to medicines, many ethical drugmakers will be aware that the peculiarities of the US$9.1bn Brazilian market will allow scope for even greater sales of quasi-illicit "generics." Meanwhile, the final shape of further regulation governing the decree is still awaited.